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CSL Limited to Apply for License to Market Influenza Vaccine in the U.S.; Major Vaccine Manufacturer to Double Capacity |
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07 Feb 2006 |
NEW YORK, NY, USA | Feb 07, 2006 | CSL Limited (ASX: CSL), a global, specialty biopharmaceutical company headquartered in Melbourne, Australia, today announced plans to introduce its influenza vaccine into the U.S. market.
Speaking at Merrill Lynch's Global Pharmaceutical and Biotechnology Conference here, CSL Chief Executive Officer and Managing Director Dr. Brian McNamee said, "CSL is the leading producer of influenza vaccine in the Southern Hemisphere and has a long heritage in biological research and manufacture. With the planned expansion of our influenza vaccine production capabilities, we look forward to working with the Food and Drug Administration (FDA) on the licensing of our vaccine in the U.S."
Dr. McNamee announced a U.S. $60 million investment in plant and equipment to double capacity at its Melbourne facility to approximately 40 million doses per season, making it one of the largest vaccine manufacturing plants in the world.
"This will increase the diversity of supply in the U.S., helping to meet the public health need for vaccinations identified by the Centers for Disease Control and Prevention and other policy makers," Dr. McNamee added.
CSL plans to initiate a human clinical study of the vaccine later this year and submit a Biologics License Application (BLA) within 12 months for both multi-dose vial and thimerosal-free single-dose syringe products. Contingent upon regulatory approval, the company intends to have vaccine available for the 2007-2008 season. The company plans to supply up to 20 million doses to the U.S. as the expanded plant comes online in 2008.
CSL has manufactured influenza vaccine in its Melbourne facility since 1968. CSL-branded influenza vaccines are approved and marketed in 16 countries worldwide. The company also provides bulk influenza vaccine for sale in 24 countries. In the United Kingdom, one in four influenza vaccine recipients were vaccinated with a CSL product this season.
CSL's influenza vaccine is a purified, inactivated, trivalent influenza vaccine propagated in embryonated eggs. Each dose contains influenza virus hemagglutinin antigens from the influenza strains recommended by the World Health Organization.
About CSL Limited
Headquartered in Melbourne, Australia, CSL Limited (ASX: CSL) is a global, specialty biopharmaceutical company that develops, manufactures and markets products to treat and prevent serious human medical conditions. CSL's subsidiary, ZLB Behring, which specializes in biotherapeutics, is located in King of Prussia, PA. The CSL Group, which also includes CSL R&D, CSL Bioplasma and CSL Pharmaceuticals, employs more than 7,000 people globally and operates in 26 countries around the world.
CSL has a proud heritage in the research-based development and production of vaccines, spanning more than 80 years. GARDASIL(R), Merck & Co., Inc.'s new HPV vaccine, is based on technology licensed by CSL to Merck in 1995. Merck has recently filed a BLA for GARDASIL with the FDA. GARDASIL is a registered trademark of Merck & Co., Inc.
SOURCE: CSL Limited |
